Federal Register notice: FDA withdraws the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the c...
Federal Register notice: CDER announces that 10/18 is the effective date that it will begin rejecting submissions that fail either Electronic Common T...
FDA posts a draft guidance entitled Facet Screw Systems Performance Criteria for Safety and Performance Based Pathway.
FDA posts a draft guidance entitled Denture Base Resins Performance Criteria for Safety and Performance Based Pathway.
A new study by FDA researchers supports an agency recommendation earlier this year that patients keep any consumer electronic devices that may create ...
FDA approves a MicroTransponder PMA for the Vivistim Paired VNS System, a vagus nerve stimulation device intended to treat moderate to severe upper ex...
Federal Register notice: FDA renews its Nonprescription Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA announces an 11/2-3 Medical Devices Advisory Committee Circulatory System Devices Panel meeting to discuss endovascular g...